Clinical Research Manager - JJMT Electrophysiology

Johnson & Johnson•Irvine, CA

7d•$117,000 - $201,250•Hybrid

About The Position

Our J&J MedTech Electrophysiology clinical team is currently recruiting for a Clinical Research Manager . The preferred location is Irvine, CA on a hybrid work schedule of 2 -3 days a week onsite. We are open to remote applicants. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive , more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/

Requirements

Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 8 years clinical research experience is required OR Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 7 years clinical research experience is required OR PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
Previous experience in managing or supervising global clinical trials
A minimum of 2 years leadership / management role within Clinical Research including 1-2 years of people management experience is required.
Clinical project leadership across multiple studies/ programs is required.
Experience working well with cross-functional teams is required.
Experience with budget planning, tracking and control is required.
Medical Device experience is required.

Nice To Haves

Bachelor’s Degree in Life Science, Physical Science, Nursing, or Biological Science is preferred.
Relevant industry certifications are preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, …).
Clinical/medical background is a plus.

Responsibilities

Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring monitoring compliance with timelines and study milestones for JNJ MedTech - Electrophysiology
Provide leadership and oversight for monitoring activities of clinical trials, aligning activities with broader study objectives, and providing input on trial design to optimize monitoring efficiency and effectiveness
Experience documenting and sharing insights into trial monitoring activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality); external partners e.g. principal investigators and support staff, and internal partners e.g. study team, management and leadership staff
Contribute to the oversight of feasibility, selection, set up, conduct and closure of a clinical trial as related to monitoring activities within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
Perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits
May be involved in the management and oversight of device ordering, tracking, and accountability of investigational products and trial materials
May be involved in the team’s interface and collaboration with key opinion leaders, site investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel
Provide input on clinical data review to prepare data for statistical analyses and publications
Lead on-site procedural protocol compliance and data collection to the clinical trial sites
Is responsible for delivery of monitoring deliverables for assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
May liaise with regional partners to ensure global standard processes are shared and applied across the organization
Plans, tracks and manages assigned monitoring project budgets to ensure adherence to business plans
Ensures resources assigned to designated clinical trials to provide quality deliverables while maintaining efficiency
Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
Should develop a strong understanding of the pipeline, product portfolio and business needs
Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed; Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures; Performs other duties assigned as needed

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits